February 2014

European Directorate for the Quality of

Medicines & HealthCare (EDQM), Council of
Europe: Blood Transfusion Activities

Mission

The work of the Council of Europe in the blood transfusion
area started in the 1950s. From the outset, the activities
were inspired by the following guiding principles:
promotion of voluntary, non-remunerated blood
donation,
mutual assistance,
optimal use of blood and blood products, and
protection of the donor and recipient.

In 2007, the scientific secretariat responsible for blood
transfusion activities at the Council of Europe was
transferred to the EDQM
1
and the European Committee on
Blood Transfusion (CD-P-TS) was given the duty to steer
and co-ordinate all activities of the Council of Europe
2
in
the field of blood transfusion.

Membership
Council of Europe member states and parties to the
European Pharmacopoeia
3
Convention are represented in
the CD-P-TS and its subordinate expert group. Non-
European observer countries to the European
Pharmacopoeia
3
Convention, including Australia, Canada,
the USA, and the European Commission, the World Health
Organization (WHO) and representatives of related and
relevant Council of Europe Committees (e.g. European
Bioethics Committees) are privileged observers to the CD-
P-TS.

European Committee on
Blood Transfusion (CD-P-TS)

The European Committee on Blood Transfusion (CD-P-TS)
undertakes to:
examine questions related to human blood transfusion,
notably on quality and safety standards and their
implementation in the different member states;
assist members states in improving blood transfusion
services and, if needed, in restructuring their blood
transfusion services to promote the principle of
voluntary non-remunerated donations;
define and promote the implementation of quality and
safety standards in the collection, storage, distribution
and use of blood and blood components;
propose ethical, safety and quality standards on
professional practices and product specifications;
ensure the transfer of knowledge and expertise and
develop the competencies of experts through training
and networking;
establish good practices in transfusion medicine and
monitor their use in Europe;
assess epidemiological risks linked to blood and its
components, in particular for new transmissible
diseases;

1
The European Directorate for the Quality of Medicines & HealthCare
contributes to protecting and promoting public and animal health in Europe by
establishing high quality standards for human and veterinary medicinal
products, blood transfusion and organ transplantations, and the safe and
appropriate use of medicines.
2
A political organisation set up in 1949, the Council of Europe works to
promote democracy and human rights continent-wide. It also develops
common responses to social, cultural and legal challenges in its 47 member
states.
3
Algeria, Argentina, Australia, Brazil, Canada, China, Israel, Madagascar,
Malaysia, Morocco, Senegal, Syria, Tunisia, United States of America.


ensure the availability of rare blood products by
providing appropriate and adapted tools such as the
European Bank of Frozen Blood of Rare Groups or other
appropriate databases.
The CD-P-TS meets at least once a year in a plenary
session.

Major Resolutions

Resolution CM/Res (2008)5 on donor responsibility and on
limitations to donation of blood and blood components,
adopted by the Committee of Ministers on 12 March 2008.
Resolution CM/Res (2013) on sexual behaviours of blood
donors that have an impact on transfusion safety, adopted
by the Committee of Ministers on 27 March 2013.

Landmark Texts

Terms of reference for 2014-2015 adopted on 21 November
2013 by the Committee of Ministers of the Council of
Europe.
Annual Report on the Collection, Testing and Use of Blood
and Blood Components in Europe, from 2001 to 2011.
Trends and Observations on the Collection, Testing and Use
of Blood and Blood Components from Council of Europe
member states, 2001-2011.
Good Practice Guidelines for Blood Establishments and
Hospital Blood Banks Required to Comply with EU Directive
2005/62/EC, adopted by the European Committee on Blood
Transfusion (CD-P-TS) of the Council of Europe in
November 2013. These Guidelines will become an integral
part of the Guide to the preparation, use and quality
assurance of blood components as of the 18
th
Edition.

Recent Publications

Guide to the preparation, use and quality assurance of blood
components 17
th
Edition (2013). The guide contains
recommendations on blood collection, blood components,
technical procedures, transfusion practices and quality
systems for blood establishments and, thus, describes a set
of measures designed to ensure the safety, quality and
efficacy of blood components. It represents a key milestone in
defining the gold standard for blood transfusion services.

Contact

Dr Guy Rautmann, Scientific Officer, Department of
Biological Standardisation and Official Medicines Control
Laboratories Network (DBO), EDQM, Council of Europe.
E-mail: Guy.Rautmann@edqm.eu
Tel.: + 33 (0)3 88 41 36 39
Fax: + 33 (0)3 88 41 27 71
Please do not hesitate to contact us via our HelpDesk:
www.edqm.eu/hd

Website Links

http://www.edqm.eu/en/healthcare-news-44.html